Last week, the Journal of Managed Care & Specialty Pharmacy (JMCP) published research revealing current pharmacist perceptions on biosimilar naming. A number of media resources have leapt on the findings of this study as indicative of a potential danger the naming system alone could cause. But I feel as though these results speak to a greater issue with interchangeability that is worth examining a little more closely.
The recent introduction in Europe of biosimilar anti-tumor necrosis factor (anti-TNF) drugs has attracted considerable attention. Much of the commentary to date has centered on price, but price tells only part of the story. Structural and perceptual differences have led to considerable heterogeneity in the levels of discounting, access, and uptake throughout and even within European markets.
Steve Miller, CMO of Express Scripts emphasizes several key points for biosimilar makers to keep in mind as they work to establish their commercialization strategy.
Patients’ concerns — though they are to be expected when a new type of treatment emerges — can prove difficult to identify with on the biosimilar manufacturing side. But these concerns are important to understand when approaching FDA AdComs.
In the last few weeks, news stories have surfaced reminding the biosimilar industry that biobetters are alive and, for the most part, well. Overall, there are upwards of 500 biobetters in development worldwide. But should the biosimilar industry really be concerned about biobetters quashing the use of biosimilars?
The adoption of single-use systems (SUS) is allowing for a shift to smaller and more flexible facilities. This article explores modern facility design options and configurations, and best practices for building a facility around SUS process technology.
Following the recent Amgen and Sandoz FDA advisory committee meetings, which focused heavily on concerns about “non-medical switching,” Dr. Steiner Madsen’s often frank discussion on how switching contributed to biosimilar uptake in Norway provides reassurance and best practices for global biosimilar makers.
Our discussion of biosimilars in this article will center on developed-market GMP biosimilars. In the European market alone, biosimilars already are a multibillion-dollar business, and one that is rapidly growing.
A recently published article in The Wall Street Journal proposes several changes to the FDA approval process. However, at a time when there should be more emphasis on accelerating biosimilar approval, this proposal very well could spell trouble for biosimilars.
This article demonstrates two methods using the success-run theorem, which uses the confidence level (how sure we are) and reliability value (valid, consistent results) to determine appropriate statistically valid sample sizes for process validation.
The demand for generic drugs is skyrocketing. According to the US FDA, nearly 8 in 10 prescriptions filled in the United States are for generic drugs. Generic drugs can be considerably less expensive while typically providing the same level of effectiveness as brand name therapeutics. The demand is intensified by initiatives such as the Affordable Care Act that intend to lower the cost of national healthcare by compelling a move toward less expensive generics and biosimilars.
The global countdown to serialization compliance is well underway. Early adopters, such as Turkey and Argentina, required serialization as early as 2010, and were followed by others such as India, China and Korea. Over the next three years, many other major markets will require adherence to their own serialization requirements, including the United States and the European Union. Expect that by 2018, serialization mandates will govern most of world’s drug supply. Biopharmaceutical companies that don’t comply will find it impossible to market their drugs in countries that have instituted serialization regulations.
Protein crystals have shown the potential to address many of the issues associated with high concentration/high viscosity solutions. While formulation and delivery challenges exist with crystallized formulations, they are not insurmountable. With access to the right level of expertise and experience, a company can manufacture its product using crystallization, thereby increasing patient compliance by offering an easier and faster form of drug delivery.
This article discusses six major types of complex formulations as well as the important equipment and processes necessary to develop GMP-compliant processes.
In this e-book, you’ll find insight and advice from some of the top experts at Phillips-Medisize who have experience navigating the intertwined pathways of the drug and medtech industries that ultimately bring combination products to market.
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